Erasmus MC ATMP laboratory: proving control, continuously
Four cleanrooms, GMP compliance and genetically modified organisms. The laboratory does not only have to be in control, it has to be able to show it at any moment.
Built and validated
2019 to 2021
Cleanrooms
4
Classification
ML-I and ML-II
The build
Between 2019 and 2021 the Erasmus MC pharmacy built and validated an ATMP laboratory with four fully equipped cleanrooms, qualified for handling ML-I and ML-II genetically modified organisms.
Continuous evidence
Under a GMP compliant quality system the laboratory must demonstrate that it is continuously in control, not that it was in control the last time someone checked.
XiltriX serves as the environmental monitoring system, covering temperature, CO₂, humidity, differential pressure and particle counts, with real-time alarm services behind it.
